Dysphagia is the medical term for the symptom of difficulty in swallowing. It is a sensation that suggests difficulty in the passage of solids or liquids from the mouth to the stomach, a lack of pharyngeal sensation, or various other inadequacies of the swallowing mechanism. Individuals with difficulty swallowing may find liquids cause coughing, choking, so for such patients thickening drinks, puree, soft food enables them to swallow safely. Individuals suffering from dysphagia are often ordered onto thickened fluids and sometimes even not to eat completely by mouth based on severity of the problem. The thicker consistency makes it less likely that an individual with dysphagia will aspirate while they are drinking.
Swallowing disorders can occur in all age groups, resulting from congenital abnormalities, structural damage, and/or medical conditions. Swallowing problems are a common complaint among older individuals, and the incidence of dysphagia is higher in the elderly in patients who have had strokes, and in patients who are admitted to acute care hospitals or chronic care facilities. Other causes of dysphagia include head and neck cancer and progressive neurologic diseases like Parkinson's disease, Dementia, Multiple sclerosis, Multiple system atrophy, or Amyotrophic lateral sclerosis.
The consequences of pulmonary aspiration ranges from no injury at all, to chemical pneumonitis or pneumonia, to death within minutes from asphyxiation. These consequences depend on the volume, chemical composition, particle size, presence or absence of infectious agents and underlying health status of the person.
Another related situation with patients who have serious breathing problems or are on ventilator, tracheostomy tubes are used to provide an airway or gas ventilation path directly to the patient's trachea through a surgically made opening in the throat. In order to cause minimal trauma to the patient, the opening into the trachea is preferably made just large enough to accommodate the tube. This can make insertion of the tube through the opening difficult, since it must be pushed through resilient cartilage. Obturators can be used to provide the tube with additional stiffness and to prevent entry of tissue into the patient end of the tube. Such obturators do not significantly help insertion since they only project from the patient end by a maximum distance about equal to the internal diameter of the tube.
FIG. 1 illustrates a schematic view showing prior art tracheostomy tube installed into the trachea of a patient. As seen the air when inhaled from the nasal cavity goes through the trachea and reaches the lungs. But patients who have breathing problems the passage is blocked and a tracheaostomy tube is required. The tracheostomy tube provides an alternative passage for the air to enter and exit from the human body. In case of patients having dysphagia at least some portion of the food and liquids material taken from the mouth goes towards the trachea instead of its normal path through esophagus. This causes the food and liquid particles to go to the lungs causing trouble in breathing for the patient.
The tracheostomy tube allows the patient to breathe but the patients ventilated via a tracheostomy have assisted laryngeal speech. Laryngeal speech has been accomplished by partially deflating the cuff of the tracheostomy tube, allowing a minimal air leak around the cuff and through the larynx during the lung filling phase of ventilation. Although this technique does result in speech, the speech is intermittent and the voice is not loud enough because the air gets dispersed between two paths, first through the vocal cords and second through the tracheostomy. A speaking valve may also be used to prevent the air to leak air from the tracheostomy and redirect the exhaled air to go through the vocal cords for better phonation. The patients who suffer from dysphagia and have tracheostomy tube installed may also have problem of aspiration.
To date, there are no available effective methods and devices to stop the aspirated contents to go into the lung and at the same time keeping the ability of phonations and speaking. Several devices were invented to decrease or stop aspirated content to pass into the lungs; however none of these inventions able to help the patients who have swallowing difficulties to keep the functions of breathing and speaking and prevent the aspirated contents to go into the lungs completely at same time. For example U.S. Pat. No. 7,856,983 discloses an Apparatus for assisting phonation in a wearer of a tracheostomy tube having a first end lying outside the trachea of the wearer in the use orientation, a second end lying inside the trachea of the wearer in the use orientation, and a first lumen coupling the first and second ends of the tracheostomy tube. The tracheostomy tube may or may not include a fenestration through a sidewall of the tracheostomy tube coupling the first lumen to the outside of the tracheostomy tube. The apparatus includes a cannula for insertion into the first lumen from the first end of the tracheostomy tube. The cannula includes a first end lying outside the first end of the tracheostomy tube in the use orientation, a second, opposite end, and a second lumen coupling the first and second ends of the cannula. If the tracheostomy tube has a fenestration, the second end may lie within the first lumen adjacent and toward the first end of the tracheostomy tube from the fenestration, or generally between the first end of the tracheostomy tube and the fenestration, or adjacent the second end of the tracheostomy tube. A one-way valve is provided at the second end of the cannula. The one-way valve remains open during inhalation, allowing air to enter the lungs. While exhaling, the valve closes.
The speaking valve devices, such as the Passy-Muir speaking valve (PMV) enables phonation and improves communication by redirecting the air flow through the vocal folds, mouth and nose. Studies have shown that the passy-muir speaking valve offers patients numerous clinical benefits beyond communication. Benefits include facilitating swallowing by increasing the pharyngeal pressures needed to move the food bolus down the pharynx into the esophagus. Some studies report that when aspiration was not eliminated, it was reduced using a passy-muir speaking valve. However, studies have shown that this reduction was not quantifiably measured.
U.S. Pat. No. 5,957,978 discloses a tracheotomy tube which comprises a first port for orienting outside the neck of a wearer, a second port for orienting within the trachea of the wearer, and a passageway connecting the first and second ports to permit the flow of gases from the first port to the second port on inhalation by the wearer and from the second port to the first port on exhalation by the wearer. The tracheotomy tube further comprises a third port oriented between the first and second ports, and a valve controlling flow through the third port. The valve opens to permit flow from the passageway through the third port.
The speaking valves used with cuffless or deflated tracheostomy tube or with fenestrated trachestomy tube, so the redirected airs flow through the vocal folds, mouth and nose through the fenestration and/or around the deflated tube. Fenestrations refer to the holes in the lumen of the tracheostomy tube. These can be several small holes or one large hole. Airflow can be directed either via the tracheostomy tube (using a non-fenestrated inner lumen) or partially via the upper airway and tracheostomy tube (using the fenestrated inner or outer lumen). If the fenestrated inner lumen is inserted whilst the cuff is deflated it allows patients to breathe through the fenestration of the tracheostomy tube as well as around it. This may improve the patient's ability to vocalize. However, it may create an opportunity for the aspirated contents in patients who have swallowing difficulties to enter the lungs through the fenestration and around the deflated cuff. Basically using the fenestrated tube in patients who have swallowing disorder put them under the risk of aspiration, the holes in the tube will give the chance for aspirated contents.
Similarly U.S. Pat. No. 6,840,242 discloses a tracheostomy aspiration suction tube for management of tracheostomized patients with co-existing dysphagia allowing aspirated material to be collected and removed from the patient prior to traveling toward the lungs. The tracheostomy aspiration suction tube utilizes a primary cannula as a passageway for air to the patient's lungs, while also providing an insertion cannula capable of receiving an inflatable collection receptacle to be placed below the vocal cords. Upon inflation, the collection receptacle forms a seal with the patient's trachea, which effectively catches any aspirated material. Attached to the collection receptacle is a drainage tube connected an external suction device. The aspirated material is suctioned out of the collection receptacle and away from the patient. The collection receptacle can be removed and reinserted as needed.
The prior art teaches systems and methods for management of tracheostomized patients with co-existing dysphagia allowing aspirated material to be collected and removed prior to travelling toward the lungs, but the patients are not able to speak during the use of this device. The prior art also teaches tracheostomy devices which also allow speaking but the speech is intermittent.
In view of the limitations inherent in the available devices, there exists a need for an improved device which prevents aspirated substance from going into the lungs and same time will enable the patient to speak and the device is capable of overcoming disadvantages inherent in conventional devices in a cost effective, secure, and environmental friendly manner. The present invention fulfils this need and provides further advantages as described in the following summary.